Department: Azzur Consulting LLC
Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results.
- Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry.
- Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others.
- Understands worldwide regulations and phase appropriate applications.
- Draws insights from projects and supplemental research to help drive new and existing growth.
- Ensures activities are efficient, optimized, and client-centric.
- Highly motivated and organized, solutions oriented leader.
- Curious and adaptable - has the ability to transform knowledge into actionable activities.
- Able to produce results in a fast paced, collaborative environment.
Essential Duties and Responsibilities:
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.
- Lead and/or support the planning and execution of Automation system implementation.
- Support all Automation related activities at a client site.
- Automation Project Leader for site projects including expansions and upgrade activities, providing day to day technical support to the project team in all project phases (design, delivery, startup, commissioning, validation) and operational support.
- Generate, execute, and review Installation, Operational, and Performance Qualification protocols.
- Provide Subject Matter Expertise for capital projects, including automation system design, control system hardware, equipment design, and instrumentation start-up and troubleshooting.
- Review and critique process and automation system designs and support project lifecycle activities in alignment with an ASTM E2500 model.
- Work closely with Automation system service providers and support the project.
- Lead Automation issue identification and resolution.
- Provide technical support for troubleshooting, improving, or optimizing ongoing Manufacturing, Utilities/Facilities equipment, and systems
- 3-5 years of relevant work experience – including design, build, test and ongoing operations support.
- Experience in Validated / GMP / Change Management regulated environment.
- Distributed Control System (DCS) experience with building automation systems, troubleshooting/testing, configuration, and maintenance (software and hardware).
- Knowledge of Automated Systems including SCADA (Archestra), PLCs (Rockwell/AB, Siemens), HMIs (Factory Talk), Instrumentation.
- Experience CREATING Validation Life Cycle documentation (inception thru approval thru execution).
- Must also be familiar with the documentation standards for Design Build GMP Qualification Lifecycle maintenance utilizing quality system processes of change management/change control.
- Experience CREATING Change Controls documentation (inception thru approval thru execution).
- Ability to handle multiple assignments and priorities.
- Experience working with Rockwell Automation (PlantPAx, ControlLogix, FactoryTalk View) in project execution and lifecycle management.
- Hands on experience with OSI PI, Honeywell, Delta Controls Building Management, Intellution iFix, GE UNICORN, Delta V or Siemens Apogee a plus.
- Knowledge of process, utility and building control systems.
- Manufacturing experience, including experience managing automation projects and leading automation system design.
- Strong understanding of GMPs and good engineering practice (GEP), including GAMP, ASTM E2500, etc.